Food Advisory Committee Meeting February 24-25, 2003 Report of the Contaminants and Natural Toxicants Subcommittee (CNTS

1. Food Advisory Committee Meeting February 24-25, 2003Report of the Contaminants and Natural Toxicants Subcommittee (CNTS) Findings Henry Kim, Ph.D. Executive Secretary, CNTS Department of Health and Human Services

2. Presentation Outline • Purpose of the Subcommittee meeting • Presentations at the Subcommittee meeting • Subcommittee’s discussions and recommendations Department of Health and Human Services

3. Subcommittee Meeting Purpose • Meeting held December 4-5, 2002 • Present Components of FDA Draft Action Plan • Obtain Subcommittee Recommendations Department of Health and Human Services

4. Charge to Subcommittee The Subcommittee was asked to evaluate whether the research steps outlined in FDA’s action plan are scientifically adequate to describe and address the public health significance of acrylamide in food Department of Health and Human Services

5. Given what we know of acrylamide – toxicology, occurrence, formation, exposure, and risks: • Are the research steps appropriate to describe and address the public health significance of acrylamide in food? • Are there gaps in the research plan or areas where emphasis should be increased? • Are there priority research needs that should be addressed first? Department of Health and Human Services

6. 1. ToxicologyDr. Richard Canady, FDA • Toxicokinetics • Animal carcinogen • Human neurotoxicant • Reproductive/developmental effects • Safety/risk assessment Department of Health and Human Services

7. 2. OccurrenceDr. Steve Musser, FDA • Development and performance of an LC/MS/MS method for the quantitation of acrylamide in a wide variety of foods • Results of exploratory survey data from U.S. foods Department of Health and Human Services

8. 3. FormationDr. Lauren Jackson, FDA • Summarized mechanisms, precursors, and factors affecting acrylamide formation • Identified research needs • Discussed FDA’s Draft Action Plan for acrylamide formation • Understand conditions leading to acrylamide formation • Develop methods to prevent or reduce acrylamide formation Department of Health and Human Services

9. 4. ExposureDr. Michael DiNovi, FDA • FDA approach for exposure assessment • Occurrence/Consumption Data • Sweden exposure study • FAO/WHO exposure study • FDA’s initial exposure estimate being conducted Department of Health and Human Services

10. 5. Consumer RiskDr. David Acheson, FDA Achieving a balance: • The importance of a balanced diet • Risks from exposure to acrylamide in food • Potential dangers of inadequate cooking Department of Health and Human Services

11. Other Presentations • Opening Remarks - Joseph Levitt, FDA • Scientific Overview - Dr. Bernard Schwetz, FDA • JIFSAN Workshop - Dr. David Lineback, JIFSAN • Public Comments • Henry Chin, NFPA • Marvin Friedman, SNF • Jeff Stier, ACSH Department of Health and Human Services

12. Subcommittee Responses to Question 1: Are the research steps appropriate to describe and address public significance of acrylamide in food? YES • Supported the overall Draft Action Plan • Supported the research steps Department of Health and Human Services

13. Subcommittee Responses to Question 2: Are there gaps are in the research plan or areas where emphasis should be increased? More detailed information on: • Risk assessment • Human toxicology and epidemiology studies • Animal toxicology studies • Sampling and analytical variability • Food consumption data by various population groups Department of Health and Human Services

14. Subcommittee Responses to Question 3: Are there priority research needs that should be addressed first? • Current approach is appropriate • Methodology, occurrence, formation, exposure, and then risk • Explicit statement of research priority • Toxicology and risk assessment studies should move forward quickly • Focus on rapid/inexpensive test development • Science-based risk communication message Department of Health and Human Services

15. Subcommittee Recommendations Toxicology • Physiological studies in humans • absorption, metabolism, distribution, excretion • Toxicokinetics studies of ingested acrylamide in humans • Animal neurotoxicity and genotoxicity studies • Animal bioassay studies for carcinogenicity • Short-term studies • Dose-response relationship at lower levels - between NOAEL and tumor producing doses • Mechanism of action • Biomarker-exposure relationship in smokers Department of Health and Human Services

16. Subcommittee Recommendations Epidemiology • Highlight a separate section on epidemiology in the Draft Action Plan • More epidemiology studies in human populations • Identify/study populations w/ higher or lower exposure • Confounding factors may limit validity of study • Investigate epidemiology studies of occupational exposures • Applicable for food exposure? Department of Health and Human Services

17. Subcommittee Recommendations Exposure Assessment • Highlight exposure assessment element • Provide information about databases • Improve ability to blind data – facilitate data sharing • Statistically determine sampling sufficiency • Obtain exposure assessors input on type of foods sampled • Use food consumption data by various population groups Department of Health and Human Services

18. Subcommittee Recommendations Risk Assessment • Incorporate more information into the Draft Action Plan • Importance of risk assessment • Methodology for conducting risk assessment • Methods for incorporating developing data Department of Health and Human Services

19. Subcommittee Recommendations Risk Communication • More emphasis on FDA’s risk communication activities • Provide science-based information for dietary choices • Involve dietetic/nutrition associations in communication efforts • American Dietetic Association • American College of Nutrition • Disseminate consumer and cooking messages through extension services Department of Health and Human Services

20. Summary • Subcommittee spoke positively about FDA’s Draft Action Plan • Subcommittee generally agreed with FDA’s approach and planned research activities • Subcommittee provided recommendations on certain aspects of the plan • Toxicology • Epidemiology • Exposure assessment • Risk assessment • Risk communication Department of Health and Human Services